The Impact of Renal Transplant on Coronary Microvascular Function Among Patients With Advanced Chronic Kidney Disease

NCT07222683 | Recruiting

• 2 other identifiers: 2022P002317K23HL171893-01A1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

People with chronic kidney disease (CKD) often experience faster aging of the heart and blood vessels, which raises the risk of heart problems beyond traditional factors like high blood pressure or cholesterol. One early sign is reduced blood flow in the tiny vessels that supply the heart, measured by a positron emission tomography (PET) scan using a marker called myocardial flow reserve (MFR). In CKD, ongoing inflammation and abnormal blood vessel growth can damage these small vessels, leading to heart stiffness and weaker heart function. A kidney transplant offers a unique chance to study how better kidney function and reduced inflammation affect heart health. The observational RESTORE study ("Impact of Renal Transplant on Coronary Microvascular Function in Patients with Advanced CKD") will measure heart blood flow and function before and after transplant. The study will test whether:

1. 1.Inflammation and abnormal vessel growth are linked to poor heart blood flow and heart function in CKD.
2. 2.Kidney transplant improves heart blood flow and function.
3. 3.Lower inflammation after transplant leads to better heart health.

Conditions

Chronic Kidney Disease; Kidney Transplant; Coronary Microvascular Dysfunction (CMD); Inflammation

Keywords

chronic kidney disease; coronary microvascular dysfunction; kidney transplant; cardiovascular inflammation; dysregulated angiogenesis; coronary artery disease

Outcome Measures

Primary Outcomes (8)

• Stress Myocardial Blood Flow (MBF)

  Myocardial blood flow with hyperemic stress measured on PET myocardial perfusion imaging

  1. Transplant Arm: At baseline prior to transplant and one year after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

• Myocardial Flow Reserve (MFR)

  Ratio of stress and rest myocardial blood flow assessed by PET

  1. Transplant Arm: At baseline prior to transplant and one year after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

• Left ventricular global longitudinal strain (GLS, %)

  Left ventricular global longitudinal strain measured on echocardiography

  1. Transplant Arm: At baseline prior to transplant and one year after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

• Left ventricular mitral inflow velocity to mitral annular early diastolic relaxation velocity ration (E/E')

  E/E' measured by echocardiography

  1. Transplant Arm: At baseline prior to transplant and one year after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

• Interleukin-6 (IL-6) levels

  IL-6 levels measured via proteomics assays

  1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

• Vascular Endothelial Growth Factor A (VEGF-A)

  VEGF-A measured by proteomic assay

  1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

• Angiopoeitin-1 (ANGPT1) Levels

  ANGPT1 levels measured by proteomic assay

  1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

• Angiopoeitin-2 (ANGPT2) Levels

  ANGPT2 levels measured by proteomics

  1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

Secondary Outcomes (3)

• Left ventricular ejection fraction (LVEF)

  1. Transplant Arm: At baseline prior to transplant and one year after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

• High sensitivity c-reactive protein (hs-CRP)

  1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

• High-sensitivity Troponin

  1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

Study Arms (2)

Transplant Arm

Patients followed before and after transplant

Waitlist Control Arm

Patients followed before transplant while on the waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with advanced kidney disease who are candidates for renal transplant will be included in the RESTORE study.

You may qualify if:

• Renal transplant candidate on the waitlist
• Age greater or equal to 45 years, or if 18-44 years of age on dialysis for 5 years or more

You may not qualify if:

• Left ventricular ejection fraction (LVEF) \< 40%
• History of coronary artery bypass grafting (CABG)
• History of heart transplant
• Patients who undergo revascularization as a result of pre-transplant cardiac PET

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• American Heart Association (AHA): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (Plasma, Serum, Peripheral blood mononuclear cell PMBCs) and Urine

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Inflammation; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Daniel M Huck, MD, MPH

CONTACT

8573074000; dhuck@bwh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: October 27, 2025
• First Posted: October 30, 2025
• Study Start: March 10, 2023
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start Date: June 30, 2030 End Date: Indefinite ClinicalTrials.gov and BioLINCC will make decisions about how long to preserve the data, but no deposited data has been deleted up to now.
• Access Criteria: All summarized and completely deidentified data on ClinicalTrials.gov will be publicly accessible without restriction. Data and metadata on the data repository BioLINCC will be controlled by standard processes at BioLINCC, including requirement for being a registered user on BioLINCC, the submission of an online request form, IRB approval, a research material distribution agreement, and approval by the NHLBI Data Repository Program Officer

Locations

US (1)